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Sleep and Training Aspects in Dialysis Fatigue - Intervention Receiving Melatonin (StandFirm)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Thessaly
Sponsor:
Collaborators:
Greek Ministry of Development
Larissa University Hospital
Information provided by (Responsible Party):
Giorgos K. Sakkas, University of Thessaly
ClinicalTrials.gov Identifier:
NCT01721551
First received: October 26, 2012
Last updated: January 13, 2013
Last verified: November 2012
  Purpose

The purpose of the current study is to investigate whether changes in patients' sleep quality and quantity will be followed by improvements in parameters related to physical and mental fatigue in patients receiving hemodialysis therapy.

More specific, the current project will investigate the effect of a 6 months intradialytic exercise training (combination of aerobic and resistance training) in combination with melatonin treatment in aspects related to fatigue, quality of life and depression.


Condition Intervention Phase
Fatigue
Drug: Melatonin
Other: Exercise Training
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phase 4 Exercise Training and Melatonin Supplementation in Aspects of Fatigue in Patients Receiving Dialysis Therapy

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Levels of Fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Fatigue will be assessed by direct and indirect measurements. Physical Fatigue will be assessed by hand grip, functional tests, cardiorespiratory max test. Mental Fatigue will be assessed by questionnaires. Cognitive Fatigue will be assessed by questionnaires. Pre and Post dialysis fatigue will be assessed by hand grip and questionnaires.


Secondary Outcome Measures:
  • Body composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Muscle composition will be assessed by MRI. Body Composition will be assessed by DEXA.

  • Muscle Functionality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Muscle functionality will be assessed by functional tests. Muscle Fatigue will be assessed by a fatigue protocol.


Other Outcome Measures:
  • Quality of life aspects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depression, Quality of life will be assessed by questionnaires. Sleep quality and quantity will be assessed by questionnaires and a full night polysomnography.


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise training and Placebo
HD patients will receive a 6 months intradialytic exercise training program in combination with placebo pills.
Other: Exercise Training
The patients will be required to complete 3 exercise sessions per week for 24 weeks. Training will include a 35-45 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session followed by a resistance training session including training in 5 muscle groups (3 sets of 10 reps). The intensity will progress from 30-40% of the maximum exercise power to 60-70%.
Other Name: Cross training (combination of aerobic and resistance)
Experimental: Exercise and Melatonin
HD patients will receive a 6 months intradialytic exercise training program in combination with 2 mg of Melatonin.
Drug: Melatonin
2 mg/day, 2 hours before bed
Other Name: Circadin
Other: Exercise Training
The patients will be required to complete 3 exercise sessions per week for 24 weeks. Training will include a 35-45 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session followed by a resistance training session including training in 5 muscle groups (3 sets of 10 reps). The intensity will progress from 30-40% of the maximum exercise power to 60-70%.
Other Name: Cross training (combination of aerobic and resistance)
Experimental: Melatonin
HD patients will receive a 6 months melatonin therapy (2mg/night)
Drug: Melatonin
2 mg/day, 2 hours before bed
Other Name: Circadin
Placebo Comparator: Placebo
HD patients will receive a 6 months Placebo therapy

Detailed Description:

Chronic renal disease is a "silent epidemic" affecting up to 10% of the population in the EU, USA, and Asian with some of the sufferers progressing into end-stage renal failure.

Renal disease patients are characterized by progressively worsening muscle weakness and muscle atrophy due to both a metabolic and a disuse component collectively described as uremic myopathy. While various interventions in stable HD patients have helped these patients improve their functionality, they still have not proven enough to bring their muscle quality and quantity up to the levels of a healthy sedentary person. Moreover, patients present with sleep problems, neurological and quality of life issues, anxiety and/or symptoms of depression but most notably they complain of chronic fatigue and "lack of energy".

Other factors that contribute to the excessive fatigue are a lack of restorative sleep, excess pre-dialysis weight, poor nutritional status, restless legs syndrome and the overall mental status of the patients. Evidently, of all of these factors can contribute to a self-exacerbating process, a vicious circle, of fatigue due to inactivity and further inactivity due to fatigue. This sensation of an enduring fatigue interferes with physical and social activities and feeds perceptions of increased restrictions and barriers, and leads to a significant reduction of physical activity and functional capacity, which in turn contributes to the increased cardiovascular risk and a high mortality rate among these patients.

Rationale: The investigators hypothesize that by improving the quality of sleep will increase patients' rest levels resulting in more energy during day and therefore more physical activity, total body and mind recovery and therefore better capacity for exercise, and more secretion of growth hormone and therefore increased anabolism. Our mission is to help the HD patient to better cope with their sensation of fatigue.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult hemodialysis patients both sexes who has received regular HD treatment for at least 6 months, adequate dialysis delivery with Kt/V >1.1 and good compliance with dialysis treatment, with serum albumin > 2.5 g/dL, hemoglobin>= 11g/dL sleep onset latency > 15 minutes or sleep efficiency < 85% or arousal index > 25

Exclusion Criteria:

Patients unable to give informed consent, with opportunistic infection in the last 3 months, malignancy or infection requiring intravenous antibiotics within 2 months prior to enrollment, myoskeletal contraindication to exercise requirement for systemic anticoagulation, participating or participated in an investigational drug or medical device study within 30 days or five half-lives, pregnant, breast feed or female of childbearing potential who does not agree to remain abstinent or to use an acceptable contraceptive regimen, lactate dehydrogenase > 300U/L, prolonged heart wave (QT) interval (as defined by corrected QT (QTc) > 460 msec in males and > 470 msec in females) on screening electrocardiogram (ECG), known current alcohol or drug abuse, known or suspected hypersensitivity to the study medication or any of its ingredients,

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721551

Contacts
Contact: Giorgos K. Sakkas, PhD 30-2431-500-911 gsakkas@med.uth.gr
Contact: Christina Karatzaferi, PhD 30-24310-47015 ck@pe.uth.gr

Locations
Greece
Patsidis General Clinic Recruiting
Karditsa, Thessaly, Greece
Contact: Spyros Dovas, MD, PhD         
Sub-Investigator: Eftixios Patsidis, MD         
University Hospital of Larissa Recruiting
Larissa, Thessaly, Greece, 41110
Contact: Stefania S Grigoriou, MSc    30-2431-500-911    stefaniagrigoriou@gmail.com   
Principal Investigator: Ioannis Stefanidis, MD, PhD         
General Hospital of Trikala Recruiting
Trikala, Thessaly, Greece, 42100
Contact: Nikoloaos Tsianas, MD    24313-50122    karatsi@otenet.gr   
Sub-Investigator: Nikolaos Tsianas, MD         
Sponsors and Collaborators
University of Thessaly
Greek Ministry of Development
Larissa University Hospital
Investigators
Principal Investigator: Giorgos K. Sakkas, PhD Center for Research and Technology Thessaly - University of Thessaly
Principal Investigator: Christina Karatzaferi, PhD University of Thessaly
Study Director: Ioannis Stefanidis, MD, PhD University of Thessaly
  More Information

Publications:
Responsible Party: Giorgos K. Sakkas, Research Associate Professor, University of Thessaly
ClinicalTrials.gov Identifier: NCT01721551     History of Changes
Other Study ID Numbers: UTH2-3/10-10-2012
Study First Received: October 26, 2012
Last Updated: January 13, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Thessaly:
Dialysis fatigue,
exercise intolerance,
muscle atrophy,
cachexia,
disability,
Sleep disorders
Depression
Mental Fatigue,
Cognitive function
Physical Fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014